gudid Primary ID: 01-0130

Soft (UDI 01-0130)

Manufactured by Sterilance Medical (Suzhou) Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Soft (Model/Catalog Number: 01-0130) is a medical device manufactured by Sterilance Medical (Suzhou) Inc.. This product is indexed under FDA Product Code / Category Classification QRK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 01-0130
Product Code / EMDN: QRK
Device Name
Database Sync Date: 2026-08-09 09:21:59

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Soft?

The registered manufacturer of record for Soft is Sterilance Medical (Suzhou) Inc..

What is the Primary UDI-DI identifier for Soft?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 01-0130.

What classification code is assigned to this device?

This device is registered under product classification code QRK.

Similar Classification Devices (QRK)

Other Devices by Sterilance Medical (Suzhou) Inc.

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